BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVITA 4

    MDR report key: 2803052 · Received October 8, 2012

    Report

    Report Number
    9611500-2012-00071
    Event Type
    Injury
    Date Received
    October 8, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 12, 2012
    Manufacturer
    DRAEGER MEDICAL GMBH
    Product Code
    CBK
    PMA / PMN Number
    K961687
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN STARTED, RESULTS WILL BE REPORTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE STAFF NOTICED THAT THE PATIENT WAS NOT VENTILATED DESPITE A VOLUME CONTROLLED VENTILATION MODE WAS SELECTED. DUE TO THE USER THE DEVICE DID NOT ALARM. THE PATIENT WAS VENTILATED MANUALLY. A DISCONNECTED FILTER AT EXPIRATION WAS NOTICED. DESPITE RECONNECTED FILTER NO FLOW WAS NOTICED AT THE PATIENT." THE PATIENT WENT INTO CARDIAC ARREST, RESUSCITATION WAS SUCCESSFUL, NO PERMANENT DETERIORATION IN STATE OF HEALTH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA 4 CONTINUOUS VENTILATOR CBK DRAEGER MEDICAL GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention